FTC Alleges Misuse of Orange Book Listings: Puts10 Pharma Companies on Notice
Attorney:
Richard D. Kelly
November 10, 2023
On Tuesday, the FTC announced that it is cracking down on companies it asserts is improperly or inaccurately placing drugs on the list of FDA-approved products, known as the Orange Book. The challenge may result in removal of products from the Orange Book.<... Read more
Federal Circuit Reiterates What Constitutes A Motivation to Combine, A Reasonable Expectation of Success, and Unexpected Results in New Chemical Compounds
Attorney:
Sara Pistilli, PharmD.
August 30, 2023
In Sun Pharmaceutical Industries, Inc. v. Incyte Corporation, on August 22, 2023, the Federal Circuit affirmed a Final Written Decision of the Patent and Trial Appeal Board (the Board) of an inter partes review (IPR) asserting the claims of U.S. Patent No. 9,249,149 (the ’149 patent) as obvious under 35 U.S.C. § 103. The central argument was whether Sun’s “octo-deuterated” ruxolitinib analog (CTP-543) and “tetra-deuterated” ruxolitinib analogs, arising from claim 7 of the ’149 patent, were obvious in light of the prior art references presented by Incyte (Rodgers, Shilling, and the Concert Backgrounder).
Claim 7 recited:
The compound of claim 1, in which the compound is selected from the group consisting of:
or a pharmaceutically acceptable salt of any of the foregoing.<... Read more
No Motivation to Modify Product-Specific Method with Method Features for Different Products
Attorney:
Derek Lightner, Ph.D.
July 14, 2023
On July 10, 2023, the Patent Trial and Appeal Board (PTAB) reversed an examiner’s finding of obvious on the basis of a failure to show a motivation to modify the prior art and a lack of a reasonable expectation of success. The appeal (No. 2023-002080, USSN 15/558,153, Technology Center 1700) of Ex parte MARK HETHERINGTON began with the filing of a Notice of Appeal on May 13, 2022, after filing the national stage application on September 13, 2017. The main appealed claim recited:<... Read more
Orphan Drug Exclusivity (ODE) – FDA Continues Its Attack
Attorney:
Richard D. Kelly
June 27, 2023
Orphan drug exclusivity was created in 1983 to encourage pharmaceutical companies to develop drugs for diseases which affect less than 200,000 persons in the U.S. Jazz Pharmaceuticals developed Xwav® to treat narcolepsy, a rare sleep disorder characterized by excessive daytime sleepiness and cataplexy, voluntary muscle weakness. Xywav® received orphan drug exclusivity until July 2027 when it expires. Xywav® comprises the drug oxybate as mixed salts of calcium, magnesium, potassium, and sodium oxybate. The Orphan Drug Act 21 U.S.C. 360 cc (b) provides the exclusivity can be broken if: <... Read more
A Broad Outline of a Genus's Perimeter Is Insufficient For Written Description of the Members of the Genus
Attorney:
Marina I. Miller, Ph.D.
April 7, 2023
The Regents of the University of Minnesota (“Minnesota”) appealed from a final decision of the U.S. PTO Patent Trial and Appeal Board (“the Board”) holding that the claims of U.S. Patent 8,815,830 were unpatentable as anticipated. The Court of Appeals for the Federal Circuit (“the Court”) affirmed.<... Read more
Federal Circuit Reiterates: Isolated Natural Products Alone Are Not Patent Eligible Without A Markedly Different Characteristic
March 3, 2023
co-authored by Sara Pistilli, PharmD. and Richard D. Kelly<... Read more
Reasonable Expectation of Success in Treating Different Conditions Not Implied by Structural Similarity
Attorney:
Derek Lightner, Ph.D.
February 7, 2023
In the matter of Ex parte Taleb, et al., the Patent Trial and Appeal Board (PTAB) determined on January 31, 2023, that an examiner (James Anderson, supported by Supervisory Patent Examiners, Jeffrey Lundgren and Kortney Klinkel) failed to establish the obviousness of claims by failing to establish a reasonable expectation of success in achieving a claimed result of a method claim. The claim in question recited<... Read more
Written Description is Not Always Your Friend
Attorney:
Richard D. Kelly
November 21, 2022
While an adequate written description is essential for patentability, 35 U.S.C. § 112(a), like everything else too much can have adverse consequences as uniQure biopharma recently learned in IPR2021-00926 (IPR) involving U.S.P. 9,982,248 (‘248).<... Read more
A Class of 957 Predicted Salts Is Insufficient To Meet the ‘At Once Envisage' Standard
Attorney:
Marina I. Miller, Ph.D.
October 26, 2022
Mylan Pharmaceuticals, Inc. (“Mylan”) appealed from the final written decision of the USPTO Patent Trial and Appeal Board (the “Board”) holding that Mylan failed to show that claims 1–4, 17, 19, and 21–23 of U.S. Patent 7,326,708 (the “’708 patent”) were anticipated or would have been obvious over the cited prior art.<... Read more
Is the Supreme Court Poised to Consider the Federal Circuit's "Possession of the Invention" Definition of Written Description?
Attorney:
Richard D. Kelly
October 5, 2022
The Supreme has relisted the petition for certiorari in Juno Therapeutics, Inc. v. Kite Pharma, Inc., 21-1566 where Juno petitioned for review of the Federal Circuit’s decision reported at 10 F.4th 1330 (2021) reversing the decision of the lower court finding U.S.P. 7,446,190 to not be invalid for lack of written description or enablement and awarding damages of over $1.2 billion. While the relisting of a certiorari petition does not guarantee cert will be granted, statically since 2016 between about 30 and 40% of relisted petitions have been granted. The SCOTUS blog has detailed analysis here. Considering that the overall grant rate for petitions is only about 4% this indicates that the Juno petition has a much greater than normal possibility of being granted.<... Read more